Green Light for Contrave

Orexigen announced today that good cardiovascular safety results for Contrave in the ongoing Light Study of cardiovascular outcomes will enable them to resubmit their product to FDA within a few weeks for approval as early as June, 2014. Contrave is a product for treating obesity that combines two older drugs — naltrexone and buproprion — in a single tablet that yields better weight control than either drug alone.

FDA required Orexigen to mount this expensive cardiovascular outcomes study back in 2011 to exclude the possibility that cardiovascular risks might outweigh the obesity treatment benefits of Contrave. A small increase in heart rate and blood pressure seen in earlier studies was the reason for this requirement. Those earlier studies were too small to detect anything but a very large increase in serious cardiac events.

Orexigen is obviously pleased with this news. Said CEO Michael Narachi:

The interim analysis of the Light Study clearly achieved the goal set by the FDA. The resubmission will contain an unprecedented amount of cardiovascular outcomes data for an obesity therapeutic, and we are confident these data will support a favorable benefit-risk assessment for Contrave.

Everything we’ve seen tells us that Contrave will be a useful tool for treating obesity, with a good profile of safety and efficacy. But that reality won’t necessarily prevent a cycle of hype followed by disappointment when the hype proves to be excessive.

Stay grounded and we’ll all be better off with one more solid option for treating obesity.